Other
Drug Facts
Caution: To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.
DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
Enema
FDA Label NDC 41250-333
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Enema (NDC 41250-333). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 120 ml delivered dose), purpose, use, warnings, do not use, ask a doctor before use if you, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 120 Ml Delivered Dose)
Mineral oil 100%
Purpose
Lubricant laxative
Use
- for relief of occasional constipation
- this product generally produces bowel movement in 2 to 15 minutes
Warnings
For rectal use only.
Do Not Use
- on children under 13 years of age
- on pregnant women
- on persons with difficulty swallowing
- on bedridden patients
- if you are presently taking a stool softener laxative
- or take with meals
Ask A Doctor Before Use If You
- have already used a laxative for more than 3 days
- have abdominal pain, nausea, or vomiting
- have a sudden change in bowel habits that persist over a period of 2 weeks
Stop Use And Ask A Doctor If
- you have rectal bleeding
- you have no bowel movement within 30 minutes of enema use
Otc - Pregnancy Or Breast Feeding
As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.
Directions (Or As Directed By A Doctor)
Rectal enema dosage is 120 ml in a single daily dosage (per 24 hours).
| Adults & children 13 years old and older | 1 bottle |
| Children under 13 years old | DO NOT USE |
Other Information
- Store at 15 to 30°C (59 to 86°F).
- Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
Inactive Ingredient
None
Questions Or Comments?
866-323-0107
Principal Display Panel - 133 Ml Bottle Carton
NDC 41250-333-02
Compare to
Fleet® Mineral
Oil Enema
active ingredient*
meijer®
READY-TO-USE
enema
MINERAL OIL
LAXATIVE
SODIUM FREE
FOR RELIEF OF
OCCASIONAL
CONSTIPATION
NOT MADE
WITH NATURAL
RUBBER LATEX
1
Bottle
4.5 Fl Oz
(133 mL)
Principal Display Panel (133 mL Bottle Carton)
* Please review the disclaimer below.
